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Clinical trials for 2011-003075-11

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    The EU Clinical Trials Register currently displays   44331   clinical trials with a EudraCT protocol, of which   7364   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    1 result(s) found for: 2011-003075-11. Displaying page 1 of 1.
    EudraCT Number: 2011-003075-11 Sponsor Protocol Number: 9HB01EXT Start Date*: 2011-12-05
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant, Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes i...
    Medical condition: The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chro...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10053754 Hemophilia B without inhibitors LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) SE (Completed) PL (Completed) IT (Completed) IE (Completed) NL (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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